Quality Assurance Specialist
2 months ago
About PMT Corporation
PMT Corporation is a leading manufacturer and distributor of high-end medical devices in the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our company is built on a culture of innovation, collaboration, and excellence.
Quality Specialist Role
We are seeking a highly skilled Quality Specialist to join our team in Chanhassen, MN. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our medical devices, working closely with our Engineering and Quality Departments to ensure compliance throughout the design and manufacturing processes.
Key Responsibilities
- Perform quality assurance tasks to ensure the consistent delivery of high-quality documents, services, products, and processes.
- Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance.
- Work with Engineering and Quality Departments in product development to ensure compliance throughout design and manufacturing processes.
- Perform product registration documentation.
- Perform post-market surveillance.
- Support manufacturing risk management activities.
- Work directly with Internal Auditors as well as the Quality and Regulatory Affairs departments on compliance related matters.
- Execute data entry and data analysis.
- Aid in coordinating internal and 3rd party audits.
- Conduct complaint investigations and complete related documentation as necessary.
- Engage in Corrective Action / Preventative Action (CAPA) processes as needed.
- Provide support and leadership on development projects and quality issues to ensure timely submissions for market clearance.
- Monitor and analyze quality data to facilitate the Site Management Review process.
Requirements
- Bachelor's degree in Medical Device, Engineering, or other closely related field.
- Knowledge of Medical Device regulations such as ISO: 13485, FDA, MDSAP, and MDD/MDR.
- Highly proficient attention to detail and extremely organized.
- Excellent analytical skills.
- Strong communication and time management skills.
- Proficient in Microsoft Office Suite and Adobe.
- Able to work individually and in a team setting to accomplish goals and deadlines.
- Able to pass a pre-employment Background and Drug Screening.
PMT Corporation is an Equal Opportunity Employer
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